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This entry was published on 2014-09-22
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Registration of nonresident establishments
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 6808-b. Registration of nonresident establishments. 1. Definition.
The term "nonresident establishment" shall mean any pharmacy,
manufacturer, wholesaler, or outsourcing facility located outside of the
state that ships, mails or delivers prescription drugs or devices to
other establishments, authorized prescribers and/or patients residing in
this state. Such establishments shall include, but not be limited to,
pharmacies that transact business through the use of the internet.

2. Registration. All nonresident establishments that ship, mail, or
deliver prescription drugs and/or devices to other registered
establishments, authorized prescribers, and/or patients into this state
shall be registered with the department; except that such registration
shall not apply to intra-company transfers between any division,
affiliate, subsidiaries, parent or other entities under complete common
ownership and control. The provisions of this subdivision shall apply
solely to nonresident establishments and shall not affect any other
provision of this article.

3. Agent of record. Each nonresident establishment that ships, mails
or delivers drugs and/or devices into this state shall designate a
resident agent in this state for service of process pursuant to rule
three hundred eighteen of the civil practice law and rules.

4. Conditions of registration. As a condition of registration, a
nonresident establishment shall comply with the following requirements:

a. Be licensed and/or registered and in good standing with the state
of residence;

b. Maintain, in readily retrievable form, records of drugs and/or
devices shipped into this state;

c. Supply, upon request, all information needed by the department to
carry out the department's responsibilities under the laws and rules and
regulations pertaining to nonresident establishments;

d. Comply with all statutory and regulatory requirements of the state
where the nonresident establishment is located, for prescription drugs
or devices shipped, mailed or delivered into this state, except that for
controlled substances shipped, mailed or delivered into this state, the
nonresident pharmacy shall follow federal law and New York law relating
to controlled substances;

e. The application shall be made in the manner and form prescribed by
the department;

f. The application of establishments to be registered as a
manufacturer, wholesaler or outsourcing facility of drugs and/or devices
shall be accompanied by a fee as provided in section sixty-eight hundred
eight of this article; and

g. The application of establishments to be registered as a nonresident
pharmacy shall be accompanied by a fee of three hundred forty-five
dollars and shall be renewed triennially at a fee of two hundred sixty

5. Additional requirements. Nonresident pharmacies registered pursuant
to this section shall:

a. Provide a toll-free telephone number that is available during
normal business hours and at least forty hours per week, to enable
communication between a patient in this state and a pharmacist at the
pharmacy who has access to the patient's records; and

b. Place such toll-free telephone number on a label affixed to each
drug or device container.

6. Disciplinary action. Except in emergencies that constitute an
immediate threat to public health, the department shall not prosecute a
complaint or otherwise take formal action against a nonresident
establishment based upon delivery of a drug into this state or a
violation of law, rule, or regulation of this state if the agency having
jurisdiction in the state where the nonresident establishment is based
commences action on the violation complained of within one hundred
twenty days from the date that the violation was reported; provided
however, that the department may prosecute a complaint or take formal
action against a nonresident establishment if it determines that the
agency having jurisdiction in the state where the nonresident
establishment is based has unreasonably delayed or otherwise failed to
take prompt and appropriate action on a reported violation.

7. Revocation or suspension. A nonresident establishment that fails to
comply with the requirements of this section shall be subject to
revocation or suspension of its registration and other applicable
penalties in accordance with the provisions of article one hundred
thirty of this chapter.

8. Exception. The department may grant an exception from the
registration requirements of this section on the application of a
nonresident establishment that restricts its sale or dispensing of drugs
and/or devices to residents of this state to isolated transactions.

9. Rules and regulations. The department shall promulgate rules and
regulations to implement the provisions of this section.